U.S. FDA – Overview
We provide comprehensive regulatory solutions to support pharmaceutical, biotechnology, and medical device companies in achieving compliance with the U.S. Food and Drug Administration (FDA). Our services encompass the entire product lifecycle, ensuring efficiency, quality, and compliance with regulatory standards.
Regulatory Strategy & Consultation
Guidance on FDA requirements for drugs, biologics, and medical devices.
Investigational New Drug Applications (IND)
Full-spectrum support for Investigational New Drug (IND) applications, enabling smooth regulatory submissions and timely initiation of clinical trials.
New Drug Application (NDA)
Comprehensive regulatory support for New Drug Applications (NDA), ensuring compliant documentation and efficient pathways to product approval.
Biologics License Applications (BLA)
End-to-end regulatory support for Biologics License Applications (BLA), ensuring compliant submissions and expedited approval of biologic products.
ANDA & Generic Drug Filings
Abbreviated New Drug Applications for generic pharmaceuticals.
510(k) & PMA Submissions
(Medical Devices)
Support for device clearance and approval pathways.
Clinical Trial Applications (CTA/IND Maintenance)
Assistance with trial design, protocol submission, and ongoing amendments.
CMC Documentation & eCTD Publishing
Compilation, formatting, and submission of Chemistry, Manufacturing, and Controls (CMC) data in CTD/eCTD format.
Regulatory Compliance & Audits
Support with GMP, GLP, and GCP compliance, FDA inspections, and audit readiness.
Post-Approval & Lifecycle Management
Variations, labeling updates, safety reporting, and regulatory change submissions.
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Experience Quality Pharmaceutical Research Services
Expertly-Trained Personnel
Our team is composed of experienced professionals who are trained in the latest research techniques and technologies, ensuring the highest quality results for our clients.
Cutting-Edge Equipment
We pride ourselves on using the most advanced and up-to-date equipment for all of our pharmaceutical research projects, enabling us to deliver accurate and efficient results.
Comprehensive Services
At X Pharma Plus, we offer a wide range of services to meet all of your pharmaceutical research needs.